Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001055493
Ethics application status
Approved
Date submitted
3/08/2016
Date registered
8/08/2016
Date last updated
18/11/2021
Date data sharing statement initially provided
20/08/2019
Date results information initially provided
18/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Food Obstruction in Oesophagus and Drugs Study: A Double Blinded Randomised Control Trial of Glucagon and Glyceryl Trinitrate Versus Placebo In Soft Food Bolus Impactions
Scientific title
The Food Obstruction in Oesophagus and Drugs Study: A Double Blinded Randomised Control Trial of Glucagon and Glyceryl Trinitrate Versus Placebo In Soft Food Bolus Oesophageal Impactions
Secondary ID [1] 289613 0
Nil
Universal Trial Number (UTN)
U1111-1185-0289
Trial acronym
FOODS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soft food bolus impaction 299399 0
Condition category
Condition code
Oral and Gastrointestinal 299381 299381 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Glucagon 2mg intravenous + Glyceryl trinitrate 600mg orally administered simultaneously as a single administration

No strategy to monitor adherence is necessary as drugs will be administered by trained nursing staff.
Intervention code [1] 295221 0
Treatment: Drugs
Comparator / control treatment
Intravenous normal saline + glucose disintegrating placebo tablet orally
Control group
Placebo

Outcomes
Primary outcome [1] 298844 0
Clinical resolution of impaction by 30 minutes post administration of drugs as defined by:
a. Ability to tolerate food and fluids without regurgitation
b. No regurgitation of secretions
c. Clinical gestalt of senior ED doctor
Timepoint [1] 298844 0
30 minutes from administration of drug
Secondary outcome [1] 325390 0
Endoscopy rate which will be calculated by checking each participant's medical record for endoscopy records
Timepoint [1] 325390 0
48 hours post first presentation to the ED
Secondary outcome [2] 325391 0
Evidence of oesophageal pathology whether by direct visualisation on endoscopy or subsequent histopathological examination of biopsy specimens
Timepoint [2] 325391 0
3 months post first presentation to the ED

Eligibility
Key inclusion criteria
a. Patients with first presentation of soft food bolus impaction
b. Patients above or equal to 18 years old
c. Patients capable of furnishing informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Known oesophageal malignancy or structural abnormalities
b. Previous presentation with soft food bolus oesophageal impaction
c. Known allergy or intolerance to glucagon or GTN
d. Extrinsic or intrinsic airway compromise
e. Oesophageal impaction with inedible or hard foods (e.g. bones, pills, nails)
f. Preload dependent cardiovascular physiology (e.g. severe aortic stenosis, hypotension)
g. Known insulinoma, pheochromocytoma or glucagonoma

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Manual shuffling of envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size of 580 required to demonstrate non-inferiority of drugs regimen with placebo with an alpha of 10% and a beta of 80% assuming a control success rate of 8% and a non-inferiority limit of 5%. The control success rate is based on retrospective data generated from the same state.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
12/01/2018
Actual
1/03/2018
Date of last participant enrolment
Anticipated
1/09/2020
Actual
1/07/2021
Date of last data collection
Anticipated
1/12/2020
Actual
1/10/2021
Sample size
Target
580
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6111 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 6112 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 6113 0
Fiona Stanley Hospital - Murdoch

Funding & Sponsors
Funding source category [1] 293992 0
Self funded/Unfunded
Name [1] 293992 0
Alwin Lian
Country [1] 293992 0
Australia
Funding source category [2] 293993 0
Self funded/Unfunded
Name [2] 293993 0
Richard Holman
Country [2] 293993 0
Australia
Funding source category [3] 293994 0
Hospital
Name [3] 293994 0
Royal Perth Hospital
Country [3] 293994 0
Australia
Funding source category [4] 293995 0
Hospital
Name [4] 293995 0
Fiona Stanley Hospital
Country [4] 293995 0
Australia
Funding source category [5] 293996 0
Hospital
Name [5] 293996 0
Sir Charles Gairdner Hospital
Country [5] 293996 0
Australia
Primary sponsor type
Hospital
Name
Fiona Stanley Hospital
Address
11 Robin Warren Drive
Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 292810 0
None
Name [1] 292810 0
Address [1] 292810 0
Country [1] 292810 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295408 0
Royal Perth Hospital HREC
Ethics committee address [1] 295408 0
Royal Perth Hospital
197 Wellington Street
Perth WA 6000
Ethics committee country [1] 295408 0
Australia
Date submitted for ethics approval [1] 295408 0
27/04/2016
Approval date [1] 295408 0
25/05/2016
Ethics approval number [1] 295408 0
2016-067

Summary
Brief summary
The project aims to determine if the two commonly used drug regimens for soft food impactions in the oesophagus are better than placebo for passage of the obstructing bolus.

Retrospective data from small and poorly-designed studies have led to the recommendations for the trial of glucagon, glyceryl trinitrate (GTN) or a combination of both in soft food bolus impactions as first line management prior to endoscopy. Retrospective data from a recent audit carried out at Freemantle has demonstrated that the rate of clinical resolution was not appreciably different between patients treated with drugs and patients not treated with drugs and that a strategy of proceeding straight to endoscopy might be preferable

In order to definitively answer the question, we propose to prospectively assign patients to either a drug regimen of a) glucagon and GTN or b) placebo and observe the outcomes after 30 minutes after which the pharmacological properties of the drugs excludes a drug effect.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67198 0
Dr Alwin Lian
Address 67198 0
c/o RPH
Wellington Street
Perth WA 6000
Country 67198 0
Australia
Phone 67198 0
+61425876842
Fax 67198 0
Email 67198 0
[email protected]
Contact person for public queries
Name 67199 0
Dr Alwin Lian
Address 67199 0
c/o RPH
Wellington Street
Perth WA 6000
Country 67199 0
Australia
Phone 67199 0
+61425876842
Fax 67199 0
Email 67199 0
[email protected]
Contact person for scientific queries
Name 67200 0
Dr Alwin Lian
Address 67200 0
c/o RPH
Wellington Street
Perth WA 6000
Country 67200 0
Australia
Phone 67200 0
+61425876842
Fax 67200 0
Email 67200 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not likely to be useful


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.